19 November 2011

COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFICATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	Tetraethyllead	
CAS number:	78-00-2	
EC number:	201-075-4	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Repr. 1A

Disclaimer: comments provided during public consultation are made available in this document as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2012/10/18	Company
Hawker Beechcraft Corporation
United States	Please see attached	Thank you for the information provided.

Please refer to response to comment #4 in this section.
	
			See also:
Comment 9 attachment (GAMA Response 18 October 2012 .pdf).pdf		
8	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the adoption of this chemical to the Candidate List.	Thank you for providing your opinion.	
6	2012/10/18	Member State
Norway	It is recognised globally that lead and its compounds pose a significant risk to human health and the environment and that there remains a need for a continued focus on reducing the risks posed by these substances. The concerns for lead compounds are their reprotoxic/neurotoxic properties. The Committee for Risk Assessment under REACH has stated that no threshold for the adverse effect of lead has been identified in humans.  We would also like to stress that the long lasting harmful effects to the environment are of serious concern (cf. classification of lead compounds in general and a number of specific lead compounds in CLP concerning environmental hazard;  "Aquatic Acute 1" ("Very toxic to aquatic life") and  "Aquatic Chronic 1" ("Very toxic to aquatic life with long lasting effects"). 

The Norwegian CA supports that tetraethyllead  should be identified as a substance of very high concern and should be included in the Candidate List.
	Thank you for providing your opinion.	
5	2012/10/17	National NGO
Naturskyddsföreningen, Swedish Society for Nature Conservation (SSNC)
Sweden	The Swedish Society for Nature Conservation (SSNC) supports the proposal to categorise Tetraethyllead as a Substance of Very High Concern.
 
The SSNC is the largest and most influential environmental organisation in Sweden, currently with 192,000 members nationwide. The SSNC works to protect the natural environment and human health, and to strengthen global solidarity.	Thank you for providing your opinion.	
4	2012/10/17	Company
United Kingdom	Innospec Ltd is the sole manufacturer of tetraethyl lead (TEL) worldwide and as a consequence is the only registrant for REACH. 

Within our submitted REACH registration dossier, we classified the substance as Repr. 1A based on the relevant end point data available.  We recognise that placement on the Candidate List is primarily based on a substance’s classification and Innospec cannot disagree with the reprotox classification of TEL.  However, the production and use of TEL is already severely restricted, programmes are ongoing to eliminate its use and significant socio-economic issues exist for continuing use in the short term.  As such we do not feel that TEL is a substance that necessitates the added requirement of being placed on the Candidate List.	Thank you for your comment. 

If the substance is identified as SVHC, this information, where relevant, will be taken into account at later stages of the authorisation process.

Topics such as the availability and suitability of alternatives, socio-economic considerations regarding the benefits of a use or the (adverse) impacts of ceasing a use as well as information on the low level of risk associated to a use are important. Information regarding these topics should be provided as part of the application for authorisation (e.g. in the analysis of alternatives, the chemical safety report or the socio-economic analysis). This information will be taken into account by the Risk Assessment and Socio-Economic Analysis Committees when forming their opinions and by the Commission when taking the final decision. It may impact the decision on granting the applied for authorisation and the conditions applicable to the authorisation, such as e.g. the length of the time limited review period of the authorisation.
	
7	2012/10/16	National NGO
IEW
Belgium	We support the nomination of this chemical to the Candidate List as a substance of very high concern	Thank you for providing your opinion.	
3	2012/10/12	Member State
Germany	We appreciate ECHA´s efforts to compile SVHC-Dossiers on such short notice. We do not fully understand the selection criteria, which are different to the approach taken by the MS for SVHC-identification.
Even though these substances can easily be put on the candidate list due to their CMR-classification, careful assessment of the relevance (tonnage, wide-spread use, exposure, prevention of substitution by equally hazardous substances) should be carried out for justification of the SVHC-identification. The RMO analysis is a crucial step in the process not only to share and discuss risk management options with MS but also to provide a justification for such a far reaching measure.

The substance has not been registered. Not for all substances included in this batch of 37 SVHC-dossiers, like substances which are not registered, the inclusion on the candidate list and subsequent inclusion in Annex XIV might be the most appropriate risk management option. Without further information on potential risks that may be related to any other uses of this substance, the reason to identify this substance as SVHC remains unclear.
Therefore, we would suggest that thorough RMO analyses are prepared and shared with MSCAs as soon as possible.
	Thank you for your comment. 

In accordance with REACH Article 59 the Member States and the Commission have the right to propose substances for identification as substances of very high concern (SVHC) meeting the criteria of Article 57. 
ECHA has received a request from the Commission to prepare an Annex XV dossier proposing the identification of this substance as SVHC, which was followed by the Agency. 

Preparation of a risk management options analysis (RMOA) before proposing the identification of a substance as SVHC is a voluntary step in the co-ordination of risk management activities among the Competent Authorities for REACH but not a requirement of REACH. 

Nevertheless, ECHA agrees on the importance of identifying the most appropriate route(s) for risk management and on the co-operation and co-ordination of the regulatory risk management activities between the authorities.
 
Please note that contrary to your statement in the comment, the substance has been registered.	
2	2012/10/09	National NGO
Danish Consumer Council
Denmark	The Danish Consumer Council (DCC) supports the inclusion of the substance in the candidate list. The DCC wants dangerous chemicals in consumer products to be banned or at least minimized to the lowest possible levels. The inclusion of this substance to the candidate list is a strong signal to producers that the use of this substance should in time be stopped, and substituted with a less dangerous one.

	Thank you for providing your opinion.	
1	2012/10/01	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as SVHC.
This substance is included in the Trade Union Priority List for REACH authorisation see: http://www.etuc.org/a/6023	Thank you for providing your opinion.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2012/10/18	Company
Hawker Beechcraft Corporation
United States	Please see attached	Thank you for your comment. Please refer to response to comment #4 in the section “General comments on the SVHC proposal”.	
			See also:
Comment 9 attachment (GAMA Response 18 October 2012 .pdf).pdf		
3	2012/10/12	Member State
Germany	No information about the physical properties is given in the report or in the technical dossier. In the report a link to the Chemical Substance Search on the ECHA website is given instead. It would be better to provide these data directly in the report (and the technical dossier), so that no further search in a database is necessary.	The proposal for identifying the substance as SVHC is based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The physical properties of the substance are in this particular case neither necessary to define the identity of the substance addressed in the dossier nor to demonstrate that it meets criteria set out in Article 57. 

If however information on the physical properties would be required to describe the substance identity or to conclude on its SVHC properties those data should be included in the Annex XV dossier.

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2012/10/18	Company
Hawker Beechcraft Corporation
United States	Please see attached	Thank you for your comment and the additional information provided. Please refer to response to comment #4 in the section “General comments on the SVHC proposal”.
	
			See also:
Comment 9 attachment (GAMA Response 18 October 2012 .pdf).pdf		
4	2012/10/17	Company
United Kingdom	To support our initial comments Innospec would emphasise the following:

Control in Handling & Use

o	There is a strictly controlled supply chain in place which already restricts human and environmental exposure to TEL.
o	Innospec are the sole manufacturer of TEL based fuel additive formulations worldwide and production is limited to one plant in the UK which meets all current and proposed international regulatory, manufacturing and emissions legislation.
o	Supply is restricted to a limited number of industrial oil refineries and fuel blenders worldwide who are experienced and knowledgeable in the handling and use of TEL formulations.  These industrial users have dedicated blending facilities to ensure safe blending of TEL based products into gasoline by a small number of specially trained personnel.  These facilities are also designed to minimise releases of TEL to the environment.
o	Innospec provides safety audit, TEL handling training and emergency response services to all our customers as well as waste management and the dismantling, decontamination and destruction of redundant TEL storage and blending facilities.
o	TEL is already subject to European Union, Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals implementing the Rotterdam Convention (commonly known as Prior Informed Consent or PIC).  PIC specifically aims to protect human health and the environment by providing countries with information on how to store, transport, use and dispose of dangerous chemicals safely. 
o	TEL is not supplied to the general public so there is no consumer exposure to TEL.  Product Stewardship and Legal Compliance programmes are in place to ensure that TEL is supplied only to industrial end users.
o	TEL has one use as an antiknock (octane) additive used in leaded motor and aviation gasoline (avgas).
o	TEL is no longer used in motor gasoline in the EU so there is no exposure to leaded motor gasoline or its combustion products.
o	TEL’s only EU use is for producing a very small volume of leaded avgas (100LL grade).  TEL is blended at very low levels (ca. 2000 ppm) into the avgas which is burned in spark ignition engined aircraft.  Like motor gasoline, once blended in the fuel, there is no exposure to TEL.
o	Supply of TEL for use in motor gasoline is restricted to 3 other countries worldwide.
o	TEL is only added to motor gasoline at very low treat rates of ca. 1500 ppm and is fully soluble in the gasoline.  As such exposure to TEL once blended into the fuel does not occur.
o	Leaded avgas is also produced in a limited number of countries (less than 20) worldwide.  Like motor gasoline, refineries producing avgas are totally reliant on Innospec to provide the TEL required.
o	In conclusion, there is no consumer exposure to TEL, use of the substance is heavily restricted and maximum efforts already go into controlling exposure by the industrial users.

Future of the Product

o	TEL is already no longer used in motor gasoline in the EU.
o	Of the 3 remaining countries worldwide supplied with TEL for use in motor gasoline, all are in the process of upgrading their oil refineries or introducing programmes to produce gasoline without lead.  This process is forecast to be complete in the next 2-3 years.
o	Studies to find a suitable alternative to TEL in avgas are already ongoing.  In particular these are being led by the Legislators and General Aviation (GA) industry stakeholders in the USA.
o	Innospec are part of the Co-ordinating Research Council (CRC) Unleaded Avgas Group in the US who are working with the US EPA, FAA and all other GA Stakeholders to identify a suitable unleaded avgas replacement.  This programme will also consider the testing requirements, manufacture and distribution of any replacement fuel as well as a programme to recertify the existing aircraft fleet to run on it.  Full details of this programme can be found at:
 http://www.faa.gov/regulations_policies/rulemaking/committees/documents/media/Avgas.ARC.RR.2.17.12.pdf
o	This programme has targeted the identification of a TEL replacement by 2018 with full implementation expected to take at least a further 4 years in the USA.  Other countries worldwide may take longer to fully introduce unleaded avgas fuel.
o	In conclusion, TEL is already in the process of being phased out of fuels worldwide.  For motor gasoline uses this will be complete in the next 2-3 years.  For avgas, a programme is in place to identify suitable alternatives within the next 6 years.  Further restrictions do not therefore appear necessary at this stage.

Socio-economic impact

o	Until the 3 remaining countries still using leaded motor gasoline complete their oil refinery upgrading programmes, they are totally reliant on TEL, and therefore Innospec, to enable them to produce gasoline of sufficient quality to operate their vehicle fleets.  No viable alternative exists in the meantime.
o	The bulk of TEL required for avgas is for the US market where GA is an essential part of the social and economic fabric of the country, especially the agricultural industry.
o	Due to the much higher octane quality of aviation gasoline compared to motor gasoline, there are significant technical and socio-economic issues surrounding the necessity for TEL in avgas.
o	There is still no technically suitable alternative to TEL in avgas; all of the chemicals used as alternatives to phase out TEL from motor gasoline have significant drawbacks when used in aviation engines.
o	The aviation fleet has a very long average life span (30 plus years) compared to motor vehicle fleet (ca 10 years).  These older aircraft are specifically designed to operate on high octane leaded fuels so a quick phaseout of leaded avgas is not possible without significant economic hardship on the General Aviation (GA) industry to buy new engines/aircraft.
o	Most importantly, without high octane leaded avgas, safety of a significant portion of the GA fleet may be compromised due to the negative impact on power, fuel economy and materials compatibility.
o	Whilst the US EPA/FAA/industry led programme to identify suitable alternative high octane avgas is ongoing, the GA industry is totally reliant on the availability of leaded avgas and therefore TEL.
o	To conclude, whilst programmes to substitute TEL in both motor gasoline and avgas fuels are already ongoing, there are no technical alternatives and there are significant socio-economic issues which preclude an early phaseout of the substance before these programmes are complete.  As the only producer of TEL worldwide, the remaining users worldwide are totally reliant upon our continued production until this time.
	Thank you for your comment and the additional information provided.

The current proposal only concerns identifying the substance as a substance of very high concern (SVHC) in accordance with REACH Article 59(2). However, if the substance is identified as SVHC, information in relation to controls under other legislation, use, exposure, alternatives and risks will be taken account of at later stages of the authorisation process.

Even though information provided during public consultation is taken into account, we would like to stress that the registrations are the standard tool and route to communicate information on a substance and its uses to the authorities The registrations are the authorities’ principal source of information when assessing the need of further risk management for a substance or (some of) its uses. Therefore, it is of utmost importance that registrants keep the information provided in the registration dossiers up to date and adequately describing the current use and exposure situation, including the operational conditions and risk management measures in place.
If certain uses are not covered by the provided exposure scenarios, downstream users can either communicate this through supply chain communication (via their suppliers) to the registrants, who then need to update their registrations accordingly, or prepare their specific chemical safety report and submit a downstream user report to ECHA.

Please also consider response to comment #4 in the section “general comments on the SVHC proposal”.

Attachments

Comment number	Public attachment	
9	
Comment 9 attachment (GAMA Response 18 October 2012 .pdf).pdf